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疼痛临床试验临床研究方法学的进展。

Advances in clinical research methodology for pain clinical trials.

机构信息

University of Pennsylvania, Philadelphia, Pennsylvania, USA.

出版信息

Nat Med. 2010 Nov;16(11):1284-93. doi: 10.1038/nm.2249. Epub 2010 Oct 14.

DOI:10.1038/nm.2249
PMID:20948532
Abstract

Pain is a ubiquitous phenomenon, but the experience of pain varies considerably from person to person. Advances in understanding of the growing number of pathophysiologic mechanisms that underlie the generation of pain and the influence of the brain on the experience of pain led to the investigation of numerous compounds for treating pain. Improved knowledge of the subjective nature of pain, the variations in the measurement of pain, the mind-body placebo effect and the impact of differences in the conduct of a clinical trial on the outcome have changed approaches to design and implement studies. Careful consideration of how these concepts affect the choice of study population, the randomization and blinding process, the measurement and collection of data, and the analysis and interpretation of results should improve the quality of clinical trials for potential pain therapies.

摘要

疼痛是一种普遍存在的现象,但每个人的疼痛体验却有很大的差异。随着对越来越多的潜在疼痛产生的病理生理机制以及大脑对疼痛体验的影响的深入了解,人们开始研究许多用于治疗疼痛的化合物。对疼痛的主观性、疼痛测量的变化、身心安慰剂效应以及临床试验实施方式的差异对结果的影响有了更深入的认识,这改变了研究设计和实施的方法。仔细考虑这些概念如何影响研究人群的选择、随机化和盲法过程、数据的测量和收集,以及结果的分析和解释,应该能够提高潜在疼痛治疗的临床试验质量。

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